Cerebral PalsyNCT03862625
Seating System for Scoliosis in Non-ambulatory Children With Cerebral Palsy: A Pilot Randomized Controlled Trial
A study testing a modular adaptive seating system and home exercise program for scoliosis in people with Cerebral Palsy and Neuromuscular Scoliosis, run by Merve Damla Korkmaz.
Trial summary
The effect of a modular seating system on coronal and sagittal balance of the spine and pelvic obliquity in children with non-ambulatory (Gross Motor Function Classification System Level IV-V) and scoliosis The hypothesis in our study is; a modular adaptive seating system prevents the progression of spinal curvature… Read more about this study
- Who is it for?
- Ages 6 to 15 years
- Conditions the study is for
- Cerebral Palsy, Neuromuscular Scoliosis
- What is being tested?
- a modular adaptive seating system and home exercise program for scoliosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2016to 2 Mar 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- the participant 6 to 15 years of age during inclusion
- the participant is diagnosed as cerebral palsy by a specialist
- the participant's Cobb angle is between 10-40 degrees. (Cobb angle above 40 degrees and patients whose parents have not accepted the operation)
- There is no history of operation due to scoliosis or the decision of the operation has not been accepted by the patients and their parents
- the participant is Gross Motor Function Classification System Level 4 or 5
- Lack of contracture to prevent sitting in the lower extremity
- Parents agree to participate in the intensive therapy program and stop the therapeutic interventions for scoliosis and lower extremities during the 3-month follow-up period
Who cannot join
- Having a history of operation due to scoliosis
- The deformity in the spine is rigid
- If the curvature measured in the spine is less than 10 degrees or more than 40 degrees in the patients whose operation decision is accepted by the family
- Having a seating modification applied at least 1 year before being included in the study
- Having a spasticity and contracture to prevent sitting in the hip and knee joint
- Having a pressure ulcer to prevent the patient from sitting
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- the participant has comorbidity that is not related about cerebral palsy
- Having epileptic seizures not controlled
- Having bone operations for hip joints
About this study
Official title: The Effect of a New-designed Modular Adaptive Seating System on Coronal and Sagittal Balance of the Spine and Pelvic Obliquity in Children With Nonambulatory Cerebral Palsy and Scoliosis
The effect of a modular seating system on coronal and sagittal balance of the spine and pelvic obliquity in children with non-ambulatory (Gross Motor Function Classification System Level IV-V) and scoliosis
The hypothesis in our study is; a modular adaptive seating system prevents the progression of spinal curvature and Reimer's maturation index, improves the sagittal balance of the spine and pelvic obliquity.
Read the detailed description
Aim: The aim of this study was to evaluate the effect of a modular adaptive seating system and exercise therapy for scoliosis on the progression of spinal curvature, spinal sagittal balance and pelvic obliquity in children aged 6 to 15 years with cerebral palsy (Gross Motor Function Classification System (GMFCS) level IV-V) and scoliosis.
Materials and methods: A prospective, randomized and controlled, single-blind study was performed on 29 patients with cerebral palsy(CP). Patients were randomized into two groups. Both groups were given scoliosis home exercise program at least three days a week and 10 repetitions for each exercise in a day. In the first group, a modular adaptive seating system used for at least four hours in a day with exercise program for scoliosis. This seating system includes a sitting elevation that corrects the pelvic obliquity, the hip block that prevents the sliding from the sitting floor and a body support unit that provides the alignment of the spine and controls of the body. Cobb angle, pelvic obliquity, sagittal spino-pelvic parameters (thoracic kyphosis angle (TK), lumbar lordosis angle (LL), sagittal vertical axis (SVA), pelvic tilt (PT), pelvic incidence (PI), sacral slop (SS)) and Reimer's migration index (RMI) measurements were evaluated by Surgimap® software at the before and 3 months after treatment.
- Conditions
- Cerebral Palsy, Neuromuscular Scoliosis
- Being tested
- a modular adaptive seating system, home exercise program for scoliosis
- Keywords
- cerebral palsy, scoliosis, adaptive seating system, sagittal balance, pelvic obliquity, coronal balance
- Medical subject headings
- Cerebral Palsy, Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a modular adaptive seating systemDevice
Also called home exercise program for scoliosis
home exercise program for scoliosisOther
| Study group | Role | What they receive |
|---|---|---|
| a modular adaptive seating system | Experimental | In the first group, there is home exercises program for scoliosis and a modular adaptive seating system. Receives: Device: a modular adaptive seating system; Other: home exercise program for scoliosis |
| home exercises for scoliosis | Active comparator | In the second group there is only home exercise program for scoliosis. Receives: Other: home exercise program for scoliosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb Angle
cobb angle shows the curvature of the spine in the coronal plane
Measured: 12 weeks
Pelvic Obliquity
pelvic obliquity is posture of pelvis in relation to the ground
Measured: 12 weeks
Sagittal Balance
sagittal balance of the spine is the posture of the spine on the sagittal plane
Measured: 12 weeks
Secondary outcomes (1)
Reimer's Migration Index (RMI)
it shows the degree of hip subluxation or dislocation
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start10 Apr 2016
- Primary completion2 Dec 2018
- Study completion2 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are two groups in this study. In the first group, there is home exercises program for scoliosis and a modular adaptive seating system. In the second group there is only home exercises program for scoliosis. The nonambulatory children between the ages of 6-15 with cerebral palsy and scoliosis were randomly grouped according to the order of Pediatric Rehabilitation Unit of Istanbul University, Istanbul Faculty of Medicine, Physical Medicine and Rehabilitation Department.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merve Damla Korkmaz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Merve Damla Korkmaz, Istanbul University
- Investigators
- Merve D Korkmaz, 1, Principal investigator, Istanbul UniversityMurat Korkmaz, 2, Principal investigator, Koc University HospitalResa Aydın, 3, Study director, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03862625
- Sponsor's protocol ID
- 2016/72
- Status last verified
- Sep 2021
- First submitted
- 27 Feb 2019
- Last updated
- 20 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a New-designed Modular Adaptive Seating System on Coronal and Sagittal Balance of the Spine and Pelvic Obliquity in Children With Nonambulatory Cerebral Palsy and Scoliosis
- ClinicalTrials.gov ID
- NCT03862625
- Acronym / sponsor ID
- 2016/72
- Conditions
- Cerebral Palsy, Neuromuscular Scoliosis
- Keywords
- cerebral palsy, scoliosis, adaptive seating system, sagittal balance, pelvic obliquity, coronal balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Merve Damla KorkmazUniversity, hospital or other
- Study start
- 10 Apr 2016 (actual)
- Primary completion
- 2 Dec 2018 (actual)
- Study completion
- 2 Mar 2019 (actual)
- First posted
- 5 Mar 2019 (actual)
- Results
- Posted 2 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effect of a modular seating system on coronal and sagittal balance of the spine and pelvic obliquity in children with non-ambulatory (Gross Motor Function Classification System Level IV-V) and scoliosis
The hypothesis in our study is; a modular adaptive seating system prevents the progression of spinal curvature and Reimer's maturation index, improves the sagittal balance of the spine and pelvic obliquity.
Detailed description
Aim: The aim of this study was to evaluate the effect of a modular adaptive seating system and exercise therapy for scoliosis on the progression of spinal curvature, spinal sagittal balance and pelvic obliquity in children aged 6 to 15 years with cerebral palsy (Gross Motor Function Classification System (GMFCS) level IV-V) and scoliosis.
Materials and methods: A prospective, randomized and controlled, single-blind study was performed on 29 patients with cerebral palsy(CP). Patients were randomized into two groups. Both groups were given scoliosis home exercise program at least three days a week and 10 repetitions for each exercise in a day. In the first group, a modular adaptive seating system used for at least four hours in a day with exercise program for scoliosis. This seating system includes a sitting elevation that corrects the pelvic obliquity, the hip block that prevents the sliding from the sitting floor and a body support unit that provides the alignment of the spine and controls of the body. Cobb angle, pelvic obliquity, sagittal spino-pelvic parameters (thoracic kyphosis angle (TK), lumbar lordosis angle (LL), sagittal vertical axis (SVA), pelvic tilt (PT), pelvic incidence (PI), sacral slop (SS)) and Reimer's migration index (RMI) measurements were evaluated by Surgimap® software at the before and 3 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are two groups in this study. In the first group, there is home exercises program for scoliosis and a modular adaptive seating system. In the second group there is only home exercises program for scoliosis. The nonambulatory children between the ages of 6-15 with cerebral palsy and scoliosis were randomly grouped according to the order of Pediatric Rehabilitation Unit of Istanbul University, Istanbul Faculty of Medicine, Physical Medicine and Rehabilitation Department.
| Arm | Type | Receives |
|---|---|---|
| a modular adaptive seating system | Experimental | Device: a modular adaptive seating system, Other: home exercise program for scoliosisIn the first group, there is home exercises program for scoliosis and a modular adaptive seating system. |
| home exercises for scoliosis | Active comparator | Other: home exercise program for scoliosisIn the second group there is only home exercise program for scoliosis. |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- the participant 6 to 15 years of age during inclusion
- the participant is diagnosed as cerebral palsy by a specialist
- the participant's Cobb angle is between 10-40 degrees. (Cobb angle above 40 degrees and patients whose parents have not accepted the operation)
- There is no history of operation due to scoliosis or the decision of the operation has not been accepted by the patients and their parents
- the participant is Gross Motor Function Classification System Level 4 or 5
Key exclusion criteria (9 listed)
- Having a history of operation due to scoliosis
- The deformity in the spine is rigid
- If the curvature measured in the spine is less than 10 degrees or more than 40 degrees in the patients whose operation decision is accepted by the family
- Having a seating modification applied at least 1 year before being included in the study
- Having a spasticity and contracture to prevent sitting in the hip and knee joint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a modular adaptive seating systemAlso: home exercise program for scoliosis | Device | a modular adaptive seating system |
| home exercise program for scoliosis | Other | a modular adaptive seating system, home exercises for scoliosis |
Primary outcome
Cobb Angle
Time frame: 12 weeks
cobb angle shows the curvature of the spine in the coronal plane
Pelvic Obliquity
Time frame: 12 weeks
pelvic obliquity is posture of pelvis in relation to the ground
Sagittal Balance
Time frame: 12 weeks
sagittal balance of the spine is the posture of the spine on the sagittal plane
1 secondary outcome
Reimer's Migration Index (RMI)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve D Korkmaz, 1 principal investigator
Istanbul University
Murat Korkmaz, 2 principal investigator
Koc University Hospital
Resa Aydın, 3 study director
Istanbul University
Questions about this trial
What is this clinical trial studying?
A study testing a modular adaptive seating system and home exercise program for scoliosis in people with Cerebral Palsy and Neuromuscular Scoliosis, run by Merve Damla Korkmaz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb Angle (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.